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Wednesday, November 6, 2024

How many companies in cities across Kosciusko County received FDA citations in 2023?

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Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website

Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website

There were four companies in cities associated with Kosciusko County that received FDA citations as a result of four inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is an increase over the number of companies cited in the previous year.

Of the nine citations issued, the most common citation was 'Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established'.

Most of the companies cited were involved in the Devices sector.

Of the companies cited, three should take voluntary actions to correct their managing operations (75%). Additionally, one company had to take regulatory and/or administrative actions (25%).

The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.

The FDA is a government agency that is primarily responsible for monitoring the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety quality, according to its website.

Companies Located Within Kosciusko County Cities and the Citations They Received in 2023
Company NameArea of BusinessInspection DateIssue Cited
Jatex, Inc.Devices06/15/2023Process control procedures, Lack of or inadequate procedures
Jatex, Inc.Devices06/15/2023Lack of or inadequate complaint procedures
Martin Farm - Konrad MartinVeterinary06/21/2023ELDU - producer causes Illegal drug residue
Martin Farm - Konrad MartinVeterinary06/21/2023Drugs prohibited for extralabel use in food-producing animal(s)
Martin Farm - Konrad MartinVeterinary06/21/2023Record keeping
NG Instruments, Inc.Devices12/14/2023Lack of or inadequate process validation
NG Instruments, Inc.Devices12/14/2023Lack of or inadequate In-process acceptance procedures
NG Instruments, Inc.Devices12/14/2023Nonconforming product, Lack of or inadequate procedures
OrthoPediatrics CorporationDevices08/18/2023Lack of or inadequate complaint procedures

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